SmartPharma Group is an international, dynamically developing company providing a wide range of regulatory services in the pharmaceutical industry.
Each of our projects is a full range of services: audit, consultations, preparation of expert opinions/reports, clinical reviews, development of a project implementation strategy, as well as all necessary documents in accordance with local regulatory requirements.
Our experience of working both globally and locally, as well as understanding of communication processes with national competent authorities, help to achieve your goals efficiently.
Our team offers support at each of stage – from developing an optimal strategic registration plan to servicing the product throughout its life cycle.
Anna Popryshko – Director
Olesia Tovsta – Chief Operating Officer
Heads operations at Smart Pharma Group and participates in all business processes of the Сompany. Including expert consulting and creation of effective regulatory strategies with the help of consulting skills in the field of regulatory issues and pharmacovigilance. 20 years of experience in the pharmaceutical industry.
Olena Sokol – Regulatory Affairs Expert
Developments of a regulatory strategy for medicinal products launching, including GAP analysis of the registration dossier for the compliance to the requirements of the EU, Ukraine, CIS legislation. Regulatory support and preparation of necessary documents at each stage of the medicinal product life cycle. 20 years of experience in the pharmaceutical industry, namely in the Regulatory Affairs department.
Olena Vitenko – Regulatory Affairs Specialist
Responsible for the preparation and maintenance of registration dossiers in accordance with the requirements of Ukraine and the Eurasian Economic Union (EAEU). Reviews documentation for compliance with current legislation. 22 years of experience working in the pharmaceutical industry.
Liubov Kokoieva — Regulatory Affairs Specialist
Responsible for the preparation and maintenance of registration dossiers in accordance with the requirements of Ukraine and the Eurasian Economic Union (EAEU). Reviews documentation for compliance with current legislation. 10 years of experience working in the pharmaceutical industry.
Mariia Miliienko — Qualified Person for Pharmacovigilance / Local Contact Person for Pharmacovigilance in Ukraine
Responsible for the organization and maintenance of the pharmacovigilance system within the Company, as well as the pharmacovigilance systems of Clients in Ukraine. Conducts identification, assessment, and reporting of adverse reactions, ensures effective interaction with regulatory authorities and Clients, and monitors compliance with current legislation to minimize risks and ensure patient safety.4 years of work experience.
Galyna Kyryliva — Deputy Qualified Person for Pharmacovigilance / Deputy Local Contact Person for Pharmacovigilance in Ukraine
Participates in the organization and maintenance of the pharmacovigilance system within the Company and supports pharmacovigilance systems of Clients in Ukraine. Assists in the collection, evaluation, and reporting of adverse reactions, coordinates communication with regulatory authorities, and ensures compliance with national legislation to enhance the safety of medicinal products and protect patient health. Also serves as a project manager for pharmacovigilance services for Clients in the EAEU and CIS countries.
